FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
1. FDA extended PDUFA date for CYTK's aficamten to December 26. 2. Review needs more time for Risk Evaluation and Mitigation Strategy. 3. No new clinical data requested; REMS submission considered a major amendment. 4. CYTK remains confident in aficamten's benefit-risk profile for FDA approval. 5. Stock down 16.5% at $35.85 after the announcement.